NDC 53153-101-01 - HANSHINNOCOL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53153-101
Requested NDC
53153-101-01
Package NDCs from labels
53153-101-01, 53153-101-04, 53153-101-05
Manufacturer
Han Kook Shin Yak Pharmaceutical Co., Ltd.
Effective date
2019-02-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HANSHINNOCOL LIQUIDHan Kook Shin Yak Pharmaceutical Co., Ltd.2019-02-11HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
CHINESE CINNAMON OILINACTIVE INGREDIENTA4WO0626T5HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
GINGERINACTIVE INGREDIENTC5529G5JPQHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
JUJUBE FRUITINACTIVE INGREDIENTG55HNL2C70HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
MONOSODIUM GLUTAMATEINACTIVE INGREDIENTW81N5U6R6UHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
PAEONIA LACTIFLORA ROOTINACTIVE INGREDIENT3Z3866YW6PHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
PUERARIA MONTANA VAR. LOBATA ROOTINACTIVE INGREDIENTPET93F4I3CHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
SORBITOLINACTIVE INGREDIENT506T60A25RHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
SUCROSEINACTIVE INGREDIENTC151H8M554HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3
waterINACTIVE INGREDIENT059QF0KO0RHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 142 of 221 · 4,404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.d88e04c1-cd54-6a12-e053-2995a90a22b42024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp6299e352-116e-43f2-b40f-c704a7bd5d612024-12-23WarningsExact identifier
unii: 9D2RTI9KYH
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.11bf6e1b-aed9-4f8f-9f03-ea911ae9f7022024-12-23WarningsExact identifier
unii: 362O9ITL9D
Equaline Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINUnited Natural Foods, Inc. dba UNFIa40f5893-eb96-4e0e-b965-d78293c48dc92024-12-23WarningsExact identifier
unii: 9D2RTI9KYH
Rugby Regular Strength AcetaminophenACETAMINOPHENRUGBY LABORATORIES295b0d00-4d4a-405f-9325-d01c5d4f3ed42024-12-20WarningsExact identifier
unii: 362O9ITL9D
Tukol X-Pecto Miel Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.b9d32964-5bd7-44b0-be98-827d5310ed4f2024-12-20WarningsExact identifier
unii: 9D2RTI9KYH
Tukol Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.aef2ad43-145d-4abc-bccc-2c5fdd6882f92024-12-20WarningsExact identifier
unii: 9D2RTI9KYH
Childrens CoughDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores, Inc.50a0eaa5-fa73-4d84-86fc-3546c85cf3532024-12-20WarningsExact identifier
unii: 9D2RTI9KYH
Equate Childrens Multi symptom Cold NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee2024-12-20WarningsExact identifier
unii: 362O9ITL9D
Childrens TussnexACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company19e9678d-ac34-4af8-a80f-d08fce0a5f0e2024-12-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Service, LLC0b6689db-ea34-9a06-e063-6394a90abaf72024-12-19WarningsExact identifier
unii: 9D2RTI9KYH
Tussnex FM Cold, Flu and Sore ThroatACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company7bddce11-c227-4d95-94c1-6f41ecd7285b2024-12-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Childrens Tussnex Multi-symptom coldDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company9028676e-d725-4afe-aa14-72235825aa172024-12-19WarningsExact identifier
unii: 9D2RTI9KYH
Tussnex FM Cold and SinusACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company04c6bb6a-d2f8-4322-afba-e240e80901762024-12-19WarningsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLC53941807-072e-4783-819d-106ea904eda22024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tussnex FM Severe cough and congestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company387df403-7803-4031-915e-8de9b103a1622024-12-19WarningsExact identifier
unii: 9D2RTI9KYH
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLCe7d36246-9c80-49b6-ad4b-e38c3fd6d0682024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Maximum strength Tussnex FM DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGuardian Drug Company0bae53e3-9661-4bc6-9fcc-da7fa131b0342024-12-19WarningsExact identifier
unii: 9D2RTI9KYH
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3fe91e9f-4033-4b48-b51b-7eb67d40fa3a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Refenesen Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINReese Pharmaceutical Co6046dc50-f162-4e2d-aa3c-7d27efad477d2024-12-18WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.